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CTRI Number  CTRI/2021/10/037597 [Registered on: 27/10/2021] Trial Registered Prospectively
Last Modified On: 24/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   EFFECT OF DEXMEDETOMIDINE ON ANAESTHESIA AND ANALGESIA REQUIREMENT AND RECOVERY CHARACTERISTICS DURING BISPECTRAL INDEX GUIDED ANAESTHESIA FOR NEUROSURGERY CASES 
Scientific Title of Study   EFFECT OF DEXMEDETOMIDINE ON ANESTHESIA AND ANALGESIA REQUIREMENT DURING BISPECTRAL INDEX GUIDE ANAESTHESIA FOR NEUROSURGERY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Preeti Raj 
Designation  Junior Resident 
Affiliation  Dr D Y Patil Medical College Hospital and Research Centre 
Address  Department Of Anaesthesia Dr D Y Patil Medical College and Research Centre Pimpri

Pune
MAHARASHTRA
411018
India 
Phone  9810749754  
Fax    
Email  hipreeti20@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr VV Chari 
Designation  Professor 
Affiliation  Dr D Y Patil Medical College Hospital and Research Centre 
Address  Department Of Anaesthesia Dr D Y Patil Medical College and Research Centre Pimpri

Pune
MAHARASHTRA
411018
India 
Phone  7251888789  
Fax    
Email  v.charri@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Preeti Raj 
Designation  Junior Resident 
Affiliation  Dr D Y Patil Medical College Hospital and Research Centre 
Address  Department Of Anaesthesia Dr D Y Patil Medical College and Research Centre Pimpri


MAHARASHTRA
411018
India 
Phone  9810749754  
Fax    
Email  hipreeti20@gmail.com  
 
Source of Monetary or Material Support  
Dr DY Patil Hospital and Research centre, Pune 
 
Primary Sponsor  
Name  Dr Preeti Raj 
Address  Department Of Anaesthesia, Dr D Y Patil Medical College and Research Centre, Pune 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Preeti Raj  Department of anaesthesia, Dr. D Y Patil Medical College and Research Centre  Dr. D Y Patil Medical College and Research Centre, Sant Tukaram Nagar, Pimri, Pune-411018
Pune
MAHARASHTRA 
9810749754

hipreeti20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine  To be given during induction of anesthesia and see for haemodynamics, 0.5mcg/kg IV 
Comparator Agent  Fentanyl  To be given during induction of anaesthesia and see for haemodynamics changes as compared to dexmedetomidine group. Fentanyl will be given as 1-2mcg/kg IV 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA grade I & II
2. Ages between 18 to 60 years of either gender.
3. Haemodynamically stable patients with normal laboratory investigations.
4. Patients willing and giving consent to be a part of the study.
 
 
ExclusionCriteria 
Details  1. Patients not willing to be a part of the study.
2. Patients on pain perception modifying drugs.
3. Patients with known sensitivity to any of the drugs under study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
EFFECT OF DEXMEDETOMIDINE ON ANAESTHESIA AND ANALGESIA REQUIREMENT AND RECOVERY CHARACTERISTICS DURING BISPECTRAL INDEX GUIDED ANAESTHESIA FOR NEUROSURGERY –A RANDOMISED CLINICAL TRIAL   6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Depth of anaesthesia as per Bispectral index –guided anaesthesia.
Adverse effects if any. 
3hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   08/11/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [hipreeti20@gmail.com].

  6. For how long will this data be available start date provided 01-03-2022 and end date provided 31-12-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Goals of neuroanaesthesia are to provide good operating conditions and to ensure stable cerebral haemodynamics without sudden increase in intracranial pressure or acute brain swelling.

Furthermore, rapid recovery from anaesthesia is often required to allow immediate post operative neurological evaluation.

Anaesthesia is a balance between the amount of anaesthetic drug administered and the state of arousal of the patient. Patient movement in response to noxious stimulation remains an important sign of inadequatedepth of anaesthesia, but is unreliable and suppressed by paralysis.Traditional clinical signs such as hypertension, tachycardia, diaphoresis and lacrimation are unreliable indicators of DOA.

Depth of anaesthesia is a simplified construct of hypnosis, amnesia, antinociception and reflex suppression. A widely used method to measure inhaled anaesthetic requirement is the minimum alveolar concentration (MAC) of inhaled anaesthetic at which movement in response to nociceptive stimulus is suppressed in 50% of subjects at standard temperature and  pressure.

Most current proprietary depth of anaesthesia monitors such as Bispectral Index (BIS, Aspect Medical System, Newton, NA, USA) and Spectral Entropy (GE healthcare, Helsinki, Finland) use dimensionless monotonic index as ba measure of anaesthetic depth.

Dexmedetomidine, the pharmacologically active of isomer of medetomidine,  is a highly selective and specific α-2 adrenoceptor agonist.

Dexmedetomidine by its central sympatholytic action, promotes haemodynamic stability when used as an adjuvant during general anaesthesia. It has analgesic and anaesthetic sparing property.

However, because of its sedative property, it is unknown if the recovery from anaesthesia would be delayed when used as an continuous infusion.

The Bispectral Index(BIS) is an electroencephalogram (EEG)-derived parameter to monitor the hypnotic effects of anaesthetics.

BIS is shown to correlate well with the level of sedation produced by propofol and to accurately predict loss of consciousness.

Despite the various limitations inherent to all brain function monitors using processed EEG signals, very recent publications have confirmed the role of the BIS monitor (Medtronic, Minneapolis,MN, USA) as one of the commercially available standard devices to monitor brain function for depth of anaesthesia.


 
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